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NCT04450602 · ClinicalTrials.gov registry record · NA
A Study Evaluating the Hair Regrowth Efficacy and Safety of ALRV5XR in Female Subjects With Hair Loss
A NA study of Androgenetic Alopecia and Hair Thinning, sponsored by Arbor Life Labs.
- Completed
- Registry status
- NA
- Development phase
- 46
- Enrollment target
- 1
- Study location
NCT04450602: Completed NA study of Androgenetic Alopecia and Hair Thinning, sponsored by Arbor Life Labs.
NCT04450602 is a NA study of Androgenetic Alopecia and Hair Thinning that has completed, run by Arbor Life Labs. The registered enrollment target is 46 participants, below the 162-participant average among 16 other Androgenetic Alopecia trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04450602, a NA study of Androgenetic Alopecia and Hair Thinning, has completed, sponsored by Arbor Life Labs.
- COMPLETED
- Registry status
- NA
- Development phase
- 46 participants
- Enrollment target
- 1
- Study location
Study Summary
To demonstrate that the ALRV5XR multi-molecular targeting treatment regimen of a daily shampoo, conditioner, topical serum and oral supplement is superior to placebo in promoting hair growth as assessed by change in hair density and percentage of terminal hair regrowth after ALRV5XR therapy. This will be a single-centre, double-blind, randomized, placebo-controlled study in female subjects randomized to a 1:1 ratio of test article to placebo. Subjects will be asked to use the study products on a daily basis for the duration of the 24-week study. Subjects will take one capsule twice daily (one in the morning and one in the evening) and will be asked to use 3-7mL of the shampoo, 3-7mL of the conditioner, and 1mL of the topical nutriment daily. Subjects will receive detailed instructions regarding the order and duration of application of each product. Subjects in the active arm will receive active capsules, shampoo, conditioner and topical nutriment. Subjects on placebo will receive placebo capsules, shampoo, conditioner and topical nutriment. All subjects will be instructed to take the capsules orally, one in the morning and one in the evening, prior to consuming food. Shampoo and conditioner are to be used once per day when washing the hair and nutriment applied at the end of the day prior to bedtime. To facilitate this, subjects will receive a 3-month supply of each product (supplement, shampoo, conditioner, and scalp nutriment). Subjects will continue the daily regimen for 24 weeks, visiting the clinic at week 12 for an interim assessment.
Primary Outcome
The primary outcome will determine if the increase in terminal hair count per square centimeter from baseline to Week 24 in subjects on ALRV5XR therapy is superior to placebo, at a significance level of 5% (one tail). A two-sample t test will be used to compare differences in the mean increase in terminal hair count from baseline to Week 24 between study arms.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT ALRV5XR
- OTHER ALRV5XR Shampoo
- OTHER ALRV5XR Conditioner
- OTHER ALRV5XR Hair Follicle Serum (Nutriment)
Study Locations (1)
California
- Biometrix - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2018-04-03 |
| Est. Completion | 2018-10-23 |
| Phase | NA |
What the finished NCT04450602 record still lists
NCT04450602 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 162-participant average among 16 other Androgenetic Alopecia trials with a reported enrollment target (72% lower).
The record links to 6 conditions, with Androgenetic Alopecia appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT04450602 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04450602 about?
NCT04450602 is a clinical study titled "A Study Evaluating the Hair Regrowth Efficacy and Safety of ALRV5XR in Female Subjects With Hair Loss". To demonstrate that the ALRV5XR multi-molecular targeting treatment regimen of a daily shampoo, conditioner, topical serum and oral supplement is superior to placebo in promoting hair growth as assessed by change in hair density and percentage of terminal hair regrowth after ALRV5XR therapy. This w...
What is the current status of trial NCT04450602?
This trial is currently completed. It is a NA study. The enrollment target is 46 participants. The study started on 2018-04-03. Estimated completion is 2018-10-23.
What conditions does trial NCT04450602 study?
This clinical trial studies the following conditions: Androgenetic Alopecia, Hair Thinning, Androgenic Alopecia, Thinning Hair, Hair Loss/Baldness.
What interventions are being tested in trial NCT04450602?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), ALRV5XR (DIETARY_SUPPLEMENT), ALRV5XR Shampoo (OTHER), ALRV5XR Conditioner (OTHER), ALRV5XR Hair Follicle Serum (Nutriment) (OTHER).
Who is sponsoring clinical trial NCT04450602?
This trial is sponsored by Arbor Life Labs, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04450602 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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